Elbow assembly

ABSTRACT

An elbow assembly for a mask system includes an elbow including a slot and a port, an anti-asphyxia valve adapted to be received within the slot and including a flap portion adapted to selectively close the port depending on the presence of pressurized gas, and a clip member to secure the anti-asphyxia valve to the elbow. The clip member includes a slot that is adapted to interlock with a protrusion provided to the anti-asphyxia valve.

CROSS-REFERENCE TO APPLICATIONS

This application is the U.S. national phase of International ApplicationNo. PCT/AU2007/000836, filed Jun. 15, 2007, which designated the U.S.and claims the benefit of U.S. Provisional Application Nos. 60/814,055,filed Jun. 16, 2006, and 60/858,699, filed Nov. 14, 2006, each of whichis incorporated herein by reference in its entirety.

Also, PCT Application No. PCT/AU2006/000031, filed Jan. 12, 2006, whichclaims priority to U.S. Provisional Application No. 60/726,699, and PCTApplication No. PCT/AU2006/000770, filed Jun. 6, 2006, which claimspriority to U.S. Provisional Application Nos. 60/687,453, 60/702,582,and 60/795,562, are each incorporated herein by reference in itsentirety.

FIELD OF THE INVENTION

The present invention relates to an elbow assembly for use with a maskassembly used for treatment, e.g., of Sleep Disordered Breathing (SDB)with Continuous Positive Airway Pressure (CPAP) or Non-Invasive PositivePressure Ventilation (NPPV).

BACKGROUND OF THE INVENTION

A mask assembly typically includes a relatively rigid shell, e.g., aframe, and a patient interface, e.g., a pair of nozzles (which may be inthe form of nasal pillows, nasal prongs, cannulae, or nasal puffs) or acushion (nasal or full-face), that is supported by the rigid shell andstructured to deliver pressurized gas to the patient or user in acomfortable, sealed manner. The mask assembly is usually held in placeusing a headgear assembly.

In some applications, there may be a clinical requirement to provide themask assembly with one or more safety devices, such as means for CO₂washout, vents, anti-asphyxia valves and the like. In some cases, theseadditional components are assembled between the gas delivery conduit andthe mask assembly. Problems with prior art assemblies may include:

(a) inadvertent assembly without one or more of the safety devices;

(b) incorrect assembly/alignment; and/or

(c) incorrect re-assembly following inadvertent dis-assembly during thecourse of treatment.

Flow generators typically deliver pressurized breathable gas (air) to apatient wearing the mask assembly. In CPAP treatment, gas is deliveredto the patient's airways at about 2-30 cm H₂O above atmosphericpressure. The flow generator is generally connected to flexible tubing(air delivery tube) that is secured to the mask assembly worn by thepatient. If the flow generator's operation is interrupted as a result ofpower outage or other mechanical/electrical failure, there may be asignificant build up of carbon dioxide in the mask as the patient'sexhaled air is not washed out of outlet vents that are usually providedto the mask assembly. This may present a health risk to the patient.

Several patents have addressed this risk, e.g., by use of a safety forgas or air delivery mask assemblies. See, e.g., U.S. Pat. Nos. 3,796,216to Schwarz, and 5,438,981 to Starr et al., as well as PCT internationalapplication no. PCT/AU97/00849.

SUMMARY OF THE INVENTION

One aspect of the present invention relates to an elbow assembly for amask system including an elbow including a slot and a port, ananti-asphyxia valve adapted to be received within the slot and includinga flap portion adapted to selectively close the port depending on thepresence of pressurized gas, and a clip member to secure theanti-asphyxia valve to the elbow. The clip member includes a slot thatis adapted to interlock with a protrusion provided to the anti-asphyxiavalve. The clip member includes wings. The wings are structured suchthat the wings protrude outwardly from the elbow when the clip member issecured to the elbow.

Another aspect of the present invention relates to an elbow assembly fora mask system including an elbow including a slot and a port, ananti-asphyxia valve adapted to be received within the slot and includinga flap portion adapted to selectively close the port depending on thepresence of pressurized gas, and a clip member to secure theanti-asphyxia valve to the elbow. The clip member includes a slot thatis adapted to interlock with a protrusion provided to the anti-asphyxiavalve. The slot of the clip member is sized to prevent assembly of theflap portion of the anti-asphyxia valve through the slot of the clipmember.

Another aspect of the present invention relates to an elbow assembly fora mask system. The elbow assembly includes an elbow including a slot anda port, an anti-asphyxia valve adapted to be received within the slotand including a flap portion adapted to selectively close the portdepending on the presence of pressurized gas, and a clip member tosecure the anti-asphyxia valve to the elbow. The clip member includes aslot that is adapted to interlock with a protrusion provided to theanti-asphyxia valve. The clip member includes one or more portions thathave a textured or frosted surface.

It will of course be understood that the structural and/or functionalfeatures of the present invention may be usefully employed in fullfacial masks or nasal masks or nasal prongs, nozzles, nare seals, and/orcannulae.

Other aspects, features, and advantages of this invention will becomeapparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thisinvention.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this invention. In such drawings:

FIG. 1 shows an exemplary embodiment of a full facial mask assembly;

FIGS. 2-1 to 2-8 show various views of an elbow assembly according to anembodiment of the present invention;

FIGS. 3-1 to 3-6 show various views of an elbow of the elbow assemblyshown in FIGS. 2-1 to 2-8;

FIGS. 4-1 to 4-10 show various views of a clip member of the elbowassembly shown in FIGS. 2-1 to 2-8;

FIGS. 5-1 to 5-9 show various views of an elbow assembly according toanother embodiment of the present invention;

FIGS. 6-1 to 6-8 show various views of an elbow of the elbow assemblyshown in FIGS. 5-1 to 5-9;

FIGS. 7-1 to 7-8 show various views of a clip member of the elbowassembly shown in FIGS. 5-1 to 5-9;

FIGS. 8-1 to 8-7 show various views of an anti-asphyxia valve (AAV)according to an embodiment of the present invention;

FIG. 9 shows an anti-asphyxia valve (AAV) attached to a clip memberaccording to another embodiment of the present invention; and

FIGS. 10-1 to 10-7 show various views of a clip member according toanother embodiment of the present invention.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

FIG. 1 illustrates an exemplary embodiment of a full facial maskassembly (“FMA”) 10. As illustrated, the mask assembly 10 includes aframe 14, a cushion 16 provided to the frame 14 and adapted to form aseal with the patient's face, an elbow assembly 18 provided to the frame14 and adapted to be connected to an air delivery tube that deliversbreathable gas to the patient, and a forehead support 12 to provide asupport and stability mechanism between the mask assembly 10 and thepatient's forehead. A headgear assembly (not shown) may be removablyattached to the frame 14 (e.g., via headgear clips) and the foreheadsupport 12 to maintain the mask assembly 10 in a desired adjustedposition on the patient's face.

Further details and embodiments of such mask assemblies are disclosed inPCT Application No. PCT/AU2006/000031, the entirety incorporated hereinby reference.

1. First Illustrated Embodiment of Elbow Assembly

FIGS. 2-1 to 2-8 illustrate an elbow assembly 218 according to anembodiment of the present invention. In the illustrated embodiment, theelbow assembly 218 is adapted for use with a mask assembly of the typedescribed above in FIG. 1. However, the elbow assembly 218 may beimplemented into other mask systems, e.g., full-face mask, mouth mask,or a nasal mask.

The main components of the elbow assembly 218 are an elbow 230 (seeFIGS. 3-1 to 3-6), an anti-asphyxia valve (AAV) 250 (see FIGS. 8-1 to8-7), and a clip member 270 (see FIGS. 4-1 to 4-10) to secure the AAV250 to the elbow 230. It is noted that the AAV 250 is a common componentthat may be used in the elbow assembly 218 as well as an elbow assembly318 described in greater detail below.

1.1 Elbow

As shown in FIGS. 3-1 to 3-6, the elbow 230 includes a first portion 232provided to a mask frame and a second portion 234 provided to a swiveljoint connected to an air delivery tube. The first portion 232 includessnap-fit tabs 233, e.g., six tabs, to connect the first portion 232 tothe mask frame with a snap-fit. However, more or less snap-fit tabs maybe used, e.g., 2-10 tabs.

The second portion 234 includes snap-fit tabs 235, e.g., six tabs, toconnect the second portion 234 to the swivel joint. The snap-fitdiameter at the second portion 234 may be smaller than the snap-fitdiameter at the first portion 232 to prevent incorrect assembly. Annularrings 236, e.g., three rings, are provided on the second portion 234 forimproved seal with the swivel joint and improved manufacturability.

The elbow 230 also includes a slot 238 to receive the AAV 250, a port240 that is selectively closed by the flap portion 252 of the AAV(depending on the presence of pressurized gas), and two tabs 242 forattaching the clip member 270 with a snap-fit. As illustrated, the port240 has a central rib 241 to prevent small objects from falling in orbeing placed in the port 240 and thereby affecting AAV function.

As best shown in FIG. 2-8, the elbow 230 has a relatively thincross-section and includes a seat 244 upon which the AAV 250 can sit.The seat 244 prevents over-deflection of the flap portion 252 of the AAV250, e.g., prevents the flap portion 252 from deflecting too far towardsthe second portion 234 of the elbow 230. In addition, the seat 244prevents edges of the flap portion 252 from getting caught in the elbow230, e.g., prevents edges of the flap portion 252 from getting caughtagainst rough surfaces or flash in the elbow 230.

1.2 Clip Member

As shown in FIGS. 2-1 to 2-8, 4-1 to 4-10, and 8-1 to 8-7, the clipmember 270 interlocks with the AAV 250 to provide a sub-assembly that isremovably attached to the elbow 230 with a snap-fit. Specifically, theAAV 250, e.g., constructed of flexible silicone or other elasticmaterial, includes an arrowhead-shaped protrusion 254 that removablyinterlocks with a slot 272 provided on the clip member 270, e.g.,constructed of rigid plastic. The inside edges of the slot 272 may havea filleted, curved, chamfered, or tapered configuration to facilitateassembly of the AAV 250.

Also, the slot 272 of the clip member 270 and the protrusion 254 on theAAV 250 are relatively narrow to prevent mis-assembly, e.g., the flapportion 252 of the AAV 250 cannot be assembled through the slot 272.

The clip member 270 includes two recesses 274 that interlock withrespective tabs 242 provided to the elbow 230. As shown in FIGS. 2-1 to2-8, the elbow 230 is structured such that, when the clip member 270 isattached to the elbow 230, the clip member 270 includes portions thatare substantially flush with a surface surrounding the port 240.

The clip member 270 includes extended edges or wings 276 that protrudeoutwardly from the elbow 230 when assembled thereto. The wings 276provide easy location and removal of the clip member 270 on disassembly.In addition, the wings 276 provide a lead-in for press-fitting the clipmember 270 on assembly.

The clip member 270 includes a central vertical rib 278. As illustrated,the rib 278 has an extended height and a contour that substantiallymatches an outer surface 246 of the elbow. The rib 278 prevents assemblyof the clip member 270 if the flap portion 252 of the AAV 250 getscaught against the elbow 230 on assembly. Specifically, when the clipmember 270 is assembled to the elbow 230, the rib 278 is located againstthe elbow outer surface 246, e.g., flush against the elbow outersurface, to prevent the AAV 250 from being assembled between the clipmember 270 and the elbow 230. For example, if the clip member 270 isassembled to the elbow 230 with the AAV 230 in an incorrect orientation(e.g., the flap portion 252 of the AAV 250 positioned between the rib278 and the elbow outer surface 246), the rib 278 prevents the clipmember 270 from interlocking with the elbow 230. It would then beevident to a user that the AAV had not been correctly installed.

The rib 278 may also prevent the clip member 270 from being assembled toother elbow embodiments, e.g., the elbow 330 described below.

In an embodiment, the clip member 270 has a thickness of about 1.5 mm.However, other thicknesses are possible.

2. Second Illustrated Embodiment of Elbow Assembly

FIGS. 5-1 to 5-9 illustrate an elbow assembly 318 according to anotherembodiment of the present invention. In the illustrated embodiment, theelbow assembly 318 is adapted for use with a nasal mask system of thetype described in PCT Application No. PCT/AU2006/000770, filed Jun. 6,2006, which claims priority to U.S. Provisional Application Nos.60/687,453, 60/702,582, and 60/795,562, and PCT Application No.PCT/AU04/01832, filed Dec. 24, 2004, which are each incorporated hereinby reference in its entirety. However, the elbow assembly 318 may beimplemented into other mask systems, e.g., full-face mask, mouth mask,or a nasal mask.

The main components of the elbow assembly 318 are an elbow 330 (seeFIGS. 6-1 to 6-8), an anti-asphyxia valve (AAV) 250 (see FIGS. 8-1 to8-7), and a clip member 370 to secure the AAV 250 to the elbow 330 (seeFIGS. 7-1 to 7-8). As noted above, the AAV 250 is a common componentthat may be used in both elbow assemblies 218, 318.

2.1 Elbow

As shown in FIGS. 6-1 to 6-8, the elbow 330 includes a first portion 332connectable to a mask frame and a second portion 334 connectable to anair delivery tube. The first portion 332 of the elbow 330 is releasablyconnected to a flanged collar member provided to the mask frame in asnap-fit manner as is known from U.S. Patent Application Publication No.2003/0196656, which is incorporated herein by reference in its entirety.

The elbow 330 also includes a slot 338 to receive the AAV 250, a port340 that is selectively closed by the flap portion 252 of the AAV 250(depending on the presence of pressurized gas), and two retainingfeatures 342, e.g., recesses or protrusions, for attaching the clipmember 370 with a snap-fit. As illustrated, the port 340 has a centralrib 341 to prevent small objects from falling in or being placed in theport 340 and thereby affecting AAV function.

2.2 Clip Member

As shown in FIGS. 5-1 to 5-9, 7-1 to 7-8, and 8-1 to 8-7, the clipmember 370 interlocks with the AAV 250 to provide a sub-assembly that isremovably attached to the elbow 330 with a snap-fit. Specifically, theAAV 250, e.g., constructed of flexible silicone or other elasticmaterial, includes an arrowhead-shaped protrusion 254 that removablyinterlocks with a slot 372 provided on the clip member 370, e.g.,constructed of rigid plastic. The inside edges of the slot 372 may havea filleted, curved, chamfered, or tapered configuration to facilitateassembly of the AAV 250.

Also, the slot 372 of the clip member 370 and the protrusion 254 on theAAV 250 are relatively narrow to prevent mis-assembly, e.g., the flapportion 252 of the AAV 250 cannot be assembled through the slot 372.

The clip member 370 includes two tabs 374 that interlock with respectiveretaining features 342 provided to the elbow 330. The clip member 370also includes slightly extended edges 376. The edges 376 provide easylocation and removal of the clip member 370 on disassembly.

Also, the clip member 370 has a relatively thin cross-section to alloweasier deflection as the clip member 370 is removed by un-wrapping theclip member 370 from the elbow 330. In an embodiment, the clip member370 has a thickness of about 1.35 mm. However, other thicknesses arepossible.

In addition, the clip member 370 includes recessed sides 380 and acentral vertical rib 378 integrally molded with the clip member 370.When the clip member 370 is assembled to the elbow 330, the recessedsides 380 and central vertical rib 378 are located against the elbowouter surface 346, e.g., flush against the elbow outer surface, toprevent the AAV 250 from being assembled between the clip member 370 andthe elbow 330.

3. AAV

FIGS. 8-1 to 8-7 illustrate the AAV 250 that may be used with eitherelbow assembly 218, 318. As explained above, the AAV 250 includes anarrowhead-shaped protrusion 254 that removably interlocks with a slot272, 372 provided on the clip member 270, 370 and a flap portion 252that selectively closes an elbow port 240, 340 (depending on thepresence of pressurized gas).

FIG. 9 illustrates an alternative embodiment of an AAV 450 attached tothe clip member 270 shown in FIGS. 4-1 to 4-10. As illustrated, the flapportion 452 of the AAV 450 includes an arrangement of protrusions and/orgrooves 460 on its face.

4. Alternative Embodiment of Clip Member

FIGS. 10-1 to 10-7 illustrate a clip member 570 to secure an AAV to anelbow according to another embodiment of the present invention. The clipmember 570 is similar to the clip member 270 described above. Incontrast, the clip member 570 includes one or more portions that have atextured or frosted surface.

As illustrated, the clip member 570 includes a main body 571 andextended edges or wings 576 that protrude outwardly from the main body571. Similar to clip 270, the clip member 570 includes a slot 572adapted to removably interlock with an AAV, two recesses 574 adapted toremovably interlock with an elbow, and a central vertical rib 578 toprevent misassembly of the clip member 570 to an elbow.

In the illustrated embodiment, the clip member 570 includes a texturedor frosted surface below a parting line P (see FIG. 10-1). Specifically,a lower portion of the main body 571 and the wings 576 have a texturedor frosted surface. The area including the textured or frosted surfaceis identified in darker outline in FIGS. 10-1 to 10-4 and 10-6 to 10-7.As illustrated, the textured or frosted surface is provided to portionsof the clip member 570 that face outwardly from the elbow when the clipmember 570 is assembled thereto.

The textured or frosted surface is provided to improve grip of the clipmember 570 during assembly and disassembly with respect to the elbow.The textured or frosted surface also hides marks or imperfections on theclip member 570 caused during manufacturing, e.g., injection moldinggate marks, to improve aesthetics. In an embodiment, the textured orfrosted surface may include any suitable surface treatment or surfaceroughening/scoring that improves grip.

It should be appreciated that the textured or frosted surface may beprovided to any suitable portion of the clip member 570. Also, atextured or frosted surface may be provided to other embodiments of aclip member, e.g., clip member 370.

While the invention has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the invention is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the invention. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each independent feature orcomponent of any given assembly may constitute an additional embodiment.In addition, while the invention has particular application to patientswho suffer from OSA, it is to be appreciated that patients who sufferfrom other illnesses (e.g., congestive heart failure, diabetes, morbidobesity, stroke, barriatric surgery, etc.) can derive benefit from theabove teachings. Moreover, the above teachings have applicability withpatients and non-patients alike.

1. An elbow assembly for a mask system, comprising: an elbow including aslot and a port; an anti-asphyxia valve adapted to be received withinthe slot and including a flap portion adapted to selectively close theport depending on the presence of pressurized gas; and a clip member tosecure the anti-asphyxia valve to the elbow, the clip member including aslot that is adapted to interlock with a protrusion provided to theanti-asphyxia valve.
 2. The elbow assembly according to claim 1, whereinthe elbow includes snap-fit tabs adapted to connect the elbow to a maskframe.
 3. The elbow assembly according to claim 1, wherein the elbowincludes snap-fit tabs adapted to connect the elbow to a swivel joint.4. The elbow assembly according to claim 1, wherein the port has acentral rib.
 5. The elbow assembly according to claim 1, wherein theelbow includes a seat upon which the AAV is adapted to sit, the seatstructured to prevent over-deflection of the flap portion in use.
 6. Theelbow assembly according to claim 1, wherein the slot of the clip memberis sized to prevent assembly of the flap portion of the anti-asphyxiavalve through the slot of the clip member.
 7. The elbow assemblyaccording to claim 1, wherein the clip member has a vertical rib that islocated against an outer surface of the elbow when secured to the elbow,the rib adapted to prevent assembly of the flap portion between the riband the outer surface.
 8. The elbow assembly according to claim 1,wherein the clip member has a thickness of about 1.5 mm.
 9. The elbowassembly according to claim 1, wherein the flap portion of anti-asphyxiavalve includes an arrangement of protrusions and/or grooves on its face.10. A mask system for supplying breathable gas to a wearer, the masksystem comprising: a mask frame; and an elbow assembly according toclaim 1 connected to the mask frame.
 11. The elbow assembly according toclaim 1, wherein the clip member includes wings, the wings beingstructured such that the wings protrude outwardly from the elbow whenthe clip member is secured to the elbow.
 12. The elbow assemblyaccording to claim 1, wherein the clip member is resiliently deflectableto facilitate attachment to and removal from the elbow.
 13. The elbowassembly according to claim 1, wherein the clip member includes aportion that extends a distance along the elbow when the clip member issecured to the elbow.
 14. An elbow assembly for a mask system,comprising: an elbow including a slot and a port; an anti-asphyxia valveadapted to be received within the slot and including a flap portionadapted to selectively close the port depending on the presence ofpressurized gas; and a clip member to secure the anti-asphyxia valve tothe elbow, the clip member including a slot that is adapted to interlockwith a protrusion provided to the anti-asphyxia valve, wherein the slotof the clip member is sized to prevent assembly of the flap portion ofthe anti-asphyxia valve through the slot of the clip member.
 15. Theelbow assembly according to claim 14, wherein the clip member includeswings, the wings being structured such that the wings protrude outwardlyfrom the elbow when the clip member is secured to the elbow.
 16. Theelbow assembly according to claim 15, wherein the clip member has athickness of about 1.5 mm.
 17. The elbow assembly according to claim 14,wherein the clip member includes slightly extended edges.
 18. The elbowassembly according to claim 17, wherein the clip member has a thicknessof about 1.35 mm.
 19. The elbow assembly according to claim 14, whereinthe port has a central rib.
 20. The elbow assembly according to claim14, wherein the clip member has a vertical rib that is located againstan outer surface of the elbow when secured to the elbow, the rib adaptedto prevent assembly of the flap portion between the rib and the outersurface.
 21. An elbow assembly for a mask system, comprising: an elbowincluding a slot and a port; an anti-asphyxia valve adapted to bereceived within the slot and including a flap portion adapted toselectively close the port depending on the presence of pressurized gas;and a clip member to secure the anti-asphyxia valve to the elbow, theclip member including a slot that is adapted to interlock with aprotrusion provided to the anti-asphyxia valve, wherein the clip memberincludes one or more portions that have a textured or frosted surface.22. The elbow assembly according to claim 21, wherein the clip memberincludes a main body and wings that protrude outwardly from the mainbody.
 23. The elbow assembly according to claim 22, wherein the texturedor frosted surface is provided to a lower portion of the main body andthe wings.
 24. The elbow assembly according to claim 21, wherein thetextured or frosted surface is provided to portions of the clip memberthat face outwardly from the elbow when the clip member is assembledthereto.
 25. The elbow assembly according to claim 21, wherein thetextured or frosted surface is structured to improve grip and/or hidemarks or imperfections on the clip member.
 26. The elbow assemblyaccording to claim 21, wherein the textured or frosted surface isprovided below a parting line of the clip member.